Sex, Drugs, and Rock & Roll (FDA Style): FDA’s Unapproved Drug Machine Continues to Dole Out Enforcement and Legal Decisions

By Kurt R. Karst – 

In case you were under the impression that FDA’s interest in unapproved drug issues and the Agency’s broader Unapproved Drugs Initiative has been waning, or that the extent of FDA’s interest has merely been in sending out Warning Letters to companies promoting their unapproved products on the internet for drug uses (see here, here, and here for example), think again.  Certain actions FDA took last week serve as a good reminder that the Agency remains as interested as ever in addressing marketed unapproved drugs.    

On November 12, 2015, a Complaint for Injunctive Relief was filed in the U.S. District Court for the Middle District of Florida to enjoin and restrain James R. Hill (doing business as Viruxo LLC) from introducing into interstate commerce any unapproved drug, among other requested relief.  The Complaint was filed after the company allegedly failed to stop marketing its over-the-counter product Viruxo Immune Support as a “natural herpes medicine.”  FDA and the Federal Trade Commission (“FTC”) sent a joint Warning Letter to Viruxo on April 28, 2011 alleging that the company’s product violates both the FDC act and the FTC Act.  Both agencies asked Viruxo to “take prompt action to correct the violations described above and prevent their future recurrence,” and warned the company that “[f]ailure to do so may result in enforcement action without further notice.”  The government carried out with its threat after the company allegedly said it would remove any offending information and claims from its marketing materials, but didn’t.  (The Viruxo case is one of the many actions the Department of Justice, FTC, and FDA formally announced on November 17th, 2015 against various companies marketing allegedly violative products.)

Moving on to the glacially paced Drug Efficacy Study Implementation (“DESI”) program, which came about as a result of the enactment of the 1962 Drug Efficacy Amendments, FDA announed last Friday in a pre-publication version of a Federal Register notice published earlier this week that the Agency has finally resolved hearing requests regarding Nitroglycerin Transdermal Systems under DESI proceeding 1786 (Docket No. FDA-1977-N-0356).  That DESI proceeding was kicked off in February 1972 when FDA announced in a notice the Agency’s evaluation of reports received from the National Academy of Science/National Research Council regarding certain single-entity coronary vasodilators for indications relating to the management, prophylaxis, and treatment of angina attacks.  Several years ago, the couple remaining companies that had marketed Nitroglycerin Transdermal Systems requested that FDA withdraw marketing approvals and informed the Agency that they were no longer interested in pursuing a hearing with FDA.  Now any company that wants to put an unapproved Nitroglycerin Transdermal System into interstate commerce is on notice from FDA: “Firms should be aware that, after [November 16, 2015], FDA intends to take enforcement action without further notice against any firm that manufactures or ships in interstate commerce any unapproved product covered by this notice.”

Finally, there’s FDA’s decision on the so-called “grandfather” status of Cocaine HCl.  In a November 12, 2015 response to a February 2012 Citizen Petition (Docket No. FDA-2012-P-0189) submitted on behalf of Lannett Company, Inc. and Cody Laboratories, Inc. (collectively “Lannett”), FDA denied Lannett’s requests that FDA affirm the grandfather status of Cocaine HCl under the 1938 grandfather clause of the FDC Act and that the drug product is not subject to the statute’s approval requirements.  According to the National Drug Code Directory, Lannett has marketed four Cocaine HCl Topical Solution drug products without approval since December 1, 2008.  The company previously announced that it was pursuing FDA approval of its Cocaine HCl drug products as an anesthetic prior to a diagnostic procedure or surgery on or through accessible mucous membranes of the nasal cavities.  A Lannett-sponsored clinical study is currently recruiting subjects.   

Lannett’s petition also requested that FDA affirm the grandfather status of Oxycodone HCl.  FDA denied that portion of the Citizen Petition in a July 2012 response (see our previous post here), stating:

We are denying the requests in your petition pertaining to oxycodone HCl on two principal grounds.  First, we reject your implicit contention that oxycodone HCl products as a class are “grandfathered” under the 1938 grandfather clause.  Furthermore, the evidence provided with your petition is inadequate to demonstrate that Lannett’s Oxycodone HCl Product meets the requirements of the 1938 grandfather clause.

In the November 2015 response, FDA essentially did a “find-and replace” with the drug name from the earlier response, stating:

We are denying the requests in your petition pertaining to cocaine HCl on two principal grounds.  First, we reject your implicit contention that cocaine HCl products as a class are “grandfathered” under the 1938 grandfather clause.  Furthermore, the evidence provided with your petition is inadequate to demonstrate that Lannett’s cocaine HCl Products meets the requirements of the 1938 grandfather clause.

Although FDA’s petition decision is largely a repeat of the Agency’s previous decision with respect to Oxycodone HCl, it’s worth a read if just to provide a refresher on how narrowly FDA interprets the 1938 grandfather clause.